Which statement about regulatory submissions for high-risk medical devices is TRUE?

• A. Substantial equivalence to a predicate device is generally sufficient.
• B. Clinical data are not required under any circumstances.
• C. A design history file is not needed for submission.
• D. PMA requires substantial evidence of safety and effectiveness, including clinical data.

Answer: (D)

High-risk medical devices must go through Premarket Approval and must be supported by substantial evidence of safety and effectiveness, which almost always includes clinical data. For Class III devices, the FDA requires robust data from studies that demonstrate that the device performs safely and effectively for its intended use. This is different from the substantial equivalence pathway used for lower-risk devices, where showing that a device is substantially equivalent to a predicate can suffice. The design history file documents the design process and is part of the documentation you provide in a PMA, since thorough design controls underpin the evidence of safety and effectiveness. Saying that clinical data are not required or that a design history file isn’t needed would miss the essential requirements for high-risk devices.